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0.7%斑蝥素外用溶液:首次批准。

Cantharidin Topical Solution 0.7%: First Approval.

作者信息

Keam Susan J

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Paediatr Drugs. 2024 Jan;26(1):95-100. doi: 10.1007/s40272-023-00600-y.

DOI:10.1007/s40272-023-00600-y
PMID:38007409
Abstract

Cantharidin (YCANTH™) is a proprietary drug-device combination product containing a formulation of cantharidin 0.7% topical solution (a vesicant naturally derived from blister beetles) delivered via a single-use applicator that has been developed by Verrica Pharmaceuticals Inc. for the treatment of molluscum contagiosum and is also being developed for the treatment of warts. In July 2023, YCANTH™ (cantharidin 0.7% topical solution) was approved for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older in the USA. This article summarizes the milestones in the development of cantharidin 0.7% topical solution leading to this first approval for the topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older.

摘要

斑蝥素(YCANTH™)是一种专利药物-器械组合产品,包含0.7%斑蝥素局部溶液制剂(一种天然来源于斑蝥的发泡剂),通过一次性涂抹器给药,由Verrica制药公司开发,用于治疗传染性软疣,也正在开发用于治疗疣。2023年7月,YCANTH™(0.7%斑蝥素局部溶液)在美国被批准用于2岁及以上成人和儿童患者传染性软疣的局部治疗。本文总结了0.7%斑蝥素局部溶液的研发历程,该溶液首次获批用于2岁及以上成人和儿童患者传染性软疣的局部治疗。

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本文引用的文献

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Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review.传染性软疣病毒对免疫监视的逃避:综述
J Drugs Dermatol. 2023 Feb 1;22(2):182-189. doi: 10.36849/JDD.7230.
2
New Developing Treatments for Molluscum Contagiosum.传染性软疣的新研发治疗方法
Dermatol Ther (Heidelb). 2022 Dec;12(12):2669-2678. doi: 10.1007/s13555-022-00826-7. Epub 2022 Oct 14.
3
COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts.
跖疣局部治疗的有效性:一项回顾性队列研究。
Infect Dis Rep. 2024 Nov 26;16(6):1108-1117. doi: 10.3390/idr16060090.
COVE-1:一项2期开放标签研究,旨在评估VP-102(一种含0.7%(w/v)斑蝥素的专利药物装置产品,封闭使用)治疗寻常疣的疗效、安全性及最佳治疗方案。
Dermatol Ther (Heidelb). 2021 Oct;11(5):1623-1634. doi: 10.1007/s13555-021-00576-y. Epub 2021 Jul 21.
4
Pooled Results of Two Randomized Phase III Trials Evaluating VP-102, a Drug-Device Combination Product Containing Cantharidin 0.7% (w/v) for the Treatment of Molluscum Contagiosum.两项评价 VP-102(一种含有 0.7%(重量/体积)斑蝥素的药物-器械组合产品)治疗传染性软疣的随机 III 期临床试验的汇总结果。
Am J Clin Dermatol. 2021 Mar;22(2):257-265. doi: 10.1007/s40257-020-00570-8. Epub 2021 Feb 18.
5
A Phase 2 Open-Label Study to Evaluate VP-102 for the Treatment of Molluscum Contagiosum.一项评估 VP-102 治疗传染性软疣的 2 期开放性研究。
J Drugs Dermatol. 2021 Jan 1;20(1):70-75. doi: 10.36849/JDD.5626.
6
Safety and Efficacy of VP-102, a Proprietary, Drug-Device Combination Product Containing Cantharidin, 0.7% (w/v), in Children and Adults With Molluscum Contagiosum: Two Phase 3 Randomized Clinical Trials.含 0.7%(重量/体积)斑蝥素的专有药物-器械组合产品 VP-102 在儿童和成人传染性软疣患者中的安全性和疗效:两项 3 期随机临床试验。
JAMA Dermatol. 2020 Dec 1;156(12):1315-1323. doi: 10.1001/jamadermatol.2020.3238.
7
Topical Cantharidin in the Management of Molluscum Contagiosum: Preliminary Assessment of an Ether-free, Pharmaceutical-grade Formulation.外用斑蝥素治疗传染性软疣:无乙醚药用级制剂的初步评估
J Clin Aesthet Dermatol. 2019 Feb;12(2):27-30. Epub 2019 Feb 1.
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9
Safety and efficacy of topical cantharidin for the treatment of pediatric molluscum contagiosum: a prospective, randomized, double-blind, placebo-controlled pilot trial.局部斑蝥素治疗儿童传染性软疣的安全性和有效性:一项前瞻性、随机、双盲、安慰剂对照的初步试验。
Int J Dermatol. 2018 Aug;57(8):1001-1006. doi: 10.1111/ijd.14079. Epub 2018 Jun 15.
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Cantharide acantholysis: endogenous protease activation leading to desmosomal plaque dissolution.斑蝥性棘层松解:内源性蛋白酶激活导致桥粒斑溶解。
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